North West London Pebble Pathway: Automated OSA Diagnosis

NCT06507228 | Recruiting

• 1 other identifier: PA8366
• Study Type: interventional
• Target: 200
• Locations: 1 country
• Sites: 1

Brief Summary

Patients with obstructive sleep apnoea (OSA) wait up to two years for a diagnostic test. Early diagnosis enables optimal treatment, mitigating risks including heart failure, lung disease, and stroke. Current diagnostic approaches are expensive (£391), time-consuming (\>1-hour interpretation), uncomfortable (cables/tubes/wires), and inequitable (multiple hospital visits). Overcoming all these limitations, we have designed and will investigate a straigh-to-test automated diagnostic pathway for OSA. This will use the AcuPebble, a miniature wearable acoustic sensor and the first regulated technology for automated, at-home diagnosis. The test is cheap (\< £100); time-saving; endorsed by patients, and accessible (posted directly to patients). This project will measure the impact of a potentially transformative, innovative, and scalable diagnostic pathway using AcuPebble technology.

Conditions

Obstructive Sleep Apnea; Sleep Apnea

Outcome Measures

Primary Outcomes (1)

• Time to diagnosis

  Time to diagnosis vs. historical control group

  12 months

Secondary Outcomes (5)

• Cost saving per test

  12 months

• Test completion rate

  12 months

• Financial saving to patients from cutting journeys associated with appointments

  12 months

• Sustainability impacts by carbon footprint reduction

  12 months

• Time saving to patients from cutting journeys associated with appointments

  12 months

Study Arms (1)

NWL PEBBLE STT patients

OTHER

Real-world clinical care arm investigating novel pathway

Diagnostic Test: NWL PEBBLE STT

Interventions

NWL PEBBLE STT DIAGNOSTIC_TEST

At home testing for OSA with AcuPebble.

NWL PEBBLE STT patients

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• OSA testing referral from primary care

You may not qualify if:

• Unable to follow test instructions

Sponsors & Collaborators

• Patrik Bachtiger: lead

Study Sites (1)

Charing Cross Hospital

London, W12 0HS, United Kingdom

RECRUITING

Related Publications (1)

• Devani N, Pramono RXA, Imtiaz SA, Bowyer S, Rodriguez-Villegas E, Mandal S. Accuracy and usability of AcuPebble SA100 for automated diagnosis of obstructive sleep apnoea in the home environment setting: an evaluation study. BMJ Open. 2021 Dec 21;11(12):e046803. doi: 10.1136/bmjopen-2020-046803.

  PMID: 34933855 BACKGROUND

MeSH Terms

Conditions

Sleep Apnea, Obstructive; Sleep Apnea Syndromes

Condition Hierarchy (Ancestors)

Apnea; Respiration Disorders; Respiratory Tract Diseases; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases

Central Study Contacts

Patrik Bachtiger

CONTACT

07814396222; p.bachtiger@imperial.ac.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: NIHR Academic Clinical Lecturer

Model Details: Propspective real world implementation and health economic study; historical control group for comparison

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 18, 2024
• Study Start: July 7, 2024
• Primary Completion: December 30, 2024
• Study Completion: December 1, 2025
• Last Updated: July 18, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)